Bell will most probably bring several claims based in
products liability against Biohip. While negligence actions may also be
available in some jurisdictions, most prefer a PL approach to injuries caused by
unreasonably dangerous products.

In order to make out a PL cause of action under any
particular theory of defect, plaintiff must allege and prove that i) defendant
was a seller (not difficult here); ii) that he is a proper plaintiff (also not
difficult here after McPherson, and most likely he or his insurance
company purchased the hip directly); the product was defective (under one or
more of three theories - design, manufacturing or warning); the defect existed
at the time that the product left Biohipís possession (an issue most likely in
the mfring c/a); cause-in-fact and proximate cause; and damages.

Manufacturing Defect

In order to make out a claim of manufacturing defect the
plaintiff must allege and prove that the product was unreasonably dangerous by
virtue of a manufacturing defect - that is that it was delivered to the
plaintiff in a manner that did not conform to the productís design. This PL c/a
looks most similar to strict liability, whereas the other two theories are more
of a negligence hybrid. In this sense, if the hip was manufactured defectively,
it does not matter how careful Biohip was in testing or assuring safe
production. Strict liability cares not for fault.

While the ASTM tests did not reveal any manufacturing flaw
in the product, plaintiff will have to allege, through the use of circumstantial
evidence, that it is fair to infer that the Drís visual inspection would have
revealed a defect. This can be done in several ways, including the use of
experts who might explain that the type of fracture evidenced in the hip (once
removed from Bell) indicated a kind of defect that could have been revealed
visually prior to implantation. Here, Bellís argument will look like that in
Negri and the American Museum of Natural History cases, where
plaintiff need not rule out every other possible cause of the break, but merely
creates the inference that it more likely than not that this type of mfring
defect caused the break. (POE)

In this sense, the c/a looks somewhat like a res ipsa
claim, although res ipsa is typically used as an evidentiary short cut in
negligence, not SL, actions.

Might Biohip argue that their liability is cut off by
virtue of the Drís negligent failure to do the visual inspection? Under a SL
theory, the negligence of others is not relevant - and, as the commentators and
jurists we read indicate: SL is applied in manufacturing defect cases because of
the policy decision to include this type of liability into the cost of doing
business. Indeed, one might want to ask whether Biohip can delegate this
important quality control function to a third party.

Lastly, Biohip may argue that Bell bore some
responsibility for his injury - his weight and rigorous physical activity - but
the plaintiffís failure to exercise due care, if true, is not relevant in a SL
c/a.

Finally, regarding mfring defect, Bell might take a
McPherson approach and argue that under negligence principles, not PL,
Biohip had a duty to adequately test the product prior to selling it to Bell,
and it failed to do so here, in so far as the testing did not detect a mfring
defect. Biohip will respond that they applied the most stringent testing,
approved by the ASTM, the industry standard, and that evidenced their exercising
due care in quality control. Bell will respond that compliance with industry
custom is, typically, evidence of the exercise of due care, but nothing more -
that is, the jury must consider compliance with custom as among the factors to
weigh in making this conclusion, as was argued in Trimarco and T.J.
Hooper.

In any case, plaintiff will have to show by a POE that the
manufacturing defect caused the hip to fail - difficult here since at best heís
got circumstantial evidence there of, and without more info from experts, the
causation element will be difficult to carry.

Design Defect

Bell may also argue that the hip he received from Biohip
was unreasonably dangerous by virtue of a design defect. Here, plaintiff must
show all the same elements enumerated above, and will look to the nature of the
hipís design to show the productís defectiveness.

How Bell will make out this c/a depends upon which
jurisdiction he is in. Some jurisdictions, such as that in Soule, may
allow Bell to use a consumer expectation approach to proving defective design -
surely this will be Bellís preferred approach. Under this theory, Bell must show
that the product failed to perform as safely as an ordinary consumer (objective)
would expect. Here, Bell might reasonably have assumed that having undergone
more than the recommended physical therapy, and having engaged in not terribly
taxing activity (carrying paint cans isnít too strenuous), that the hip, some
eight months later, would not fail in this manner.

However, where the question of design defect is one which
is too technical for an ordinary consumer to form an opinion without the aid of
experts, some jurisdictions, such as that in Camacho, take the view that
a risk/utility analysis is more appropriate with respect to determining a defect
in design. Similarly, in Potter the Connecticut Supreme Court urged a
modified consumer expectation test when the evidence as to defect is quite
technical or complex.

Under a risk/utility analysis - surely Biohipís preferred
approach - the question will be whether the risks posed by the hipís design are
reasonable in light of the utility of the hip. Camacho laid out a number
of factors to be considered in making the risk/utility analysis, including the
productís usefulness, its safety, availability of substitute products or
designs/materials, feasibility of making the product safer without raising its
cost too much or significantly diminishing its utility, obviousness of the risk
to the consumer and/or ability to minimize risk with warnings, and finally the
availability of spreading the costs of a more pricey design among consumers or
through insurance.

In addition, in some jurisdictions, and under the 3d
Restatement, plaintiff will be required to produce or persuade the fact finder
that there is a reasonable alternative design - and that this design must bear a
favorable safety/cost/utility ratio.

On these facts, it is difficult to say whether Bell will
be able to prove design defect under a risk/utility analysis. Surely he will
want to look to other hips manufactured by Biohipís competitors to see if they
are stronger and price competitive.

Biohip will, no doubt, point to the fact that the FDA has
already engaged in some sort of risk/utility calculus prior to granting the
license for the hip - as they investigated safety and efficacy prior to
approving the device. Query whether that calculus is the same as that demanded
by PL law. Here Bell would argue that the FDA calculus establishes a floor of
safety, whereas Biohip will argue it establishes is ceiling.

Part of Bellís argument will be that it is foreseeable
that people of Bellís weight will need hip replacements, and will have the
Biohip product implanted. In this sense, Biohip should incorporate the stress of
a 270 pound person doing activities like carrying paint into their design of the
hip.

Warning Defect

Finally, Bell will argue that the hip was rendered
unreasonably dangerous by virtue of an inadequate warning from the manufacturer
regarding the risks of the use of this hip. Under this theory of recovery, a
product that has significant social utility, and which carries with it certain
risks, can minimize, if not eliminate, those unreasonable risks by providing
either instructions on use or warnings to the consumer. In this sense, the mfr
transfers to the consumer the risk/utility information and s/he then decides for
him or herself whether to use the product.

The default rule that the mfr must communicate these
warnings to the consumer is excepted where the product is delivered to the
consumer through a learned intermediary (LI)- such as a doctor prescribing
medication, or here, implanting a prosthetic device. As this exception is
articulated by the court in Edwards, where the learned intermediary is
given complete warnings about the risks inherent in the use of the product, the
intermediary can than filter, adjust, and translate those warnings to the
patient in light of the particularities of the patientsí
needs/vulnerabilities/conditions. The learned intermediary bar to mfr liability
for warning the consumer of risks is not engaged, however, where the warnings
provided to the LI are inadequate. Pittman provides a number of factors
to consider when assessing the adequacy of the warnings, and Hood
considers the specificity of the warnings in relation to risk.

Here, the warnings provided to Dr. Bonze indicated that
for a short time after the operation, the patient should watch his or her weight
and refrain from strenuous activity. These warnings did not indicate clearly a
risk, about which all experts seem to agree, of fracture of the hip for heavy
people. Had Bonze known this, and communicated it to Bell, he may have pursued a
different course of treatment: lose weight before the operation, choose a
different therapy, choose a different hip. Itís also not clear from the warnings
Bonze received that strenuous activity (assuming thatís what Bell was engaging
in) almost a year later might stress the hip to the point of fracture.

Finally, with respect to the FDA licensing, the govít
requires that Biohip label the product for intended use. If it had been Biohipís
intention that the product be used only for thin to moderately heavy people,
then the product should have been so labeled - thereby accomplishing the same
thing as a warning.